Childrens Loratadine

Product NDC
62011-0305
11-digit product format
620110305
Labeler code
62011
Product ID
62011-0305_29a3b58c-79eb-2168-e063-6394a90ac032
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
SOLUTION
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
ANDA076805
Marketing category
ANDA
Marketing start
2004-08-20
Substance
LORATADINE
Active strength
5 mg/5mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Childrens Loratadine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE5 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7AJO3BO7QN
Rxcui692783

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62011-0305-1Childrens Loratadine120 mL in 1 BOTTLESOLUTION1204
62011-0305-1Childrens Loratadine1 in 1 CARTONSOLUTION14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62011-0305-1ML - Milliliter62011-03055b559a22-b553-4961-9c4a-1b79f5239e0d12017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62011-0305CHILDRENS LORATADINE (LORATADINE) SOLUTION [STRATEGIC SOURCING SERVICES LLC]4Current NDC, Legacy NDC, 2 package rows20241222_280739e5-94e5-4d1e-ba65-2b4304cbac97.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
692783loratadine 5 MG in 5 mL Oral SolutionPSN280739e5-94e5-4d1e-ba65-2b4304cbac974
692783loratadine 1 MG/ML Oral SolutionSCD280739e5-94e5-4d1e-ba65-2b4304cbac974
692783loratadine 5 MG per 5 ML Oral SolutionSY280739e5-94e5-4d1e-ba65-2b4304cbac974

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62011-0305-1620110305011 BOTTLE in 1 CARTON (62011-0305-1) / 120 mL in 1 BOTTLE1 bottle2016-11-150000-00-00NoNoCurrent